| CTRI Number |
CTRI/2024/01/062030 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Quadriceps angle and balance in old population. |
|
Scientific Title of Study
|
Relationship between Quadriceps angle and balance in elderly individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Sachdev |
| Designation |
1st YEAR MPT |
| Affiliation |
College of Physiotherapy |
| Address |
Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, Gujarat.
391760
Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, Gujarat.
391760
Vadodara
GUJARAT
390006
India |
| Phone |
8460793890 |
| Fax |
|
| Email |
simransachdev83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rushikesh Joshi |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, 391760
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8141633941 |
| Fax |
|
| Email |
drrushikesh.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Joshi |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8141633941 |
| Fax |
|
| Email |
drrushikesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy and all other departments of Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Simran Sachdev |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, 391760 |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Simran Sachdev |
DHIRAJ HOSPITAL |
BLOCK NO. 4 PHYSIOTHERAPY OPD AND DHIRAJ HOSPITAL SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY, PIPARIA, WAGHODIA, VADODARA
391760
Vadodara
GUJARAT |
8460793890
simransachdev83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
older adults 65 and above
both male and female genders |
|
| ExclusionCriteria |
| Details |
participants who had undergone any recent surgeries in lower limb in last one year. participants who had any previous musculoskeletal conditions. participants with vestibular and visual problems. participants with neurological conditions and those with risk of cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quadriceps angle |
At one point that is at the time of recruitment the data will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale (BBS) |
at one point that is at the time of recruitment the data will be collected |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2024 |
| Date of Study Completion (India) |
05/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, individuals over 65 years of age will be approached about the study. They will be recruited for the study after the fulfillment of inclusion criteria. They will be given academic stress inventory and stress coping style inventory. They have to read the questions carefully and tick appropriate answers. The data will then be statistically analyzed. |